BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOPHY SM8 ADJUSTABLE VALVE / ANTECHAMBER

    MDR report key: 3918801 · Received June 24, 2014

    Report

    Report Number
    3001587388-2014-00227
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT HAS BEEN REPORTED TO THE MANUFACTURER ON (B)(6) 2014. RESULTS OF ANALYSIS WILL BE DEVELOPED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    SM8A FUNCTIONED WELL AT 70MMHG FOR NEARLY TWO MONTHS BUT IN (B)(6), EVEN AT THE SETTING OF 30, THE PATIENT CONDITION DID NOT IMPROVE. THEREFORE, THE SURGEON REPLACED IT WITH CODMAN (B)(4). THE NEW VALVE FUNCTIONS WELL AT THE SETTING OF 110MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367218 SOPHY SM8 ADJUSTABLE VALVE / ANTECHAMBER SOPHY MINI ADJUSTABLE VALVE JXG SOPHYSA SOPHY

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention